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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00820209 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with ixabepilone may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with ixabepilone works in treating patients with advanced kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: bevacizumab Drug: ixabepilone Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: flow cytometry Procedure: gene expression analysis Procedure: gene expression profiling Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: protein expression analysis Procedure: proteomic profiling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bevacizumab in Combination With Ixabepilone in Subjects With Advanced Renal Cell Carcinoma. |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline, after every 2 courses, and after completion of treatment to correlate changes in biomarkers with clinical outcomes.
Patients undergo biopsies and blood sample collection periodically for biomarker analysis. Blood samples are analyzed for protein profiling (e.g., VEGF-A, VEGFR-2, VEGFR-3, and βFGF) by ELISA; tumor endothelial markers (e.g., TEM7s, TEM8s, CD137s, CD276s, and Apelin) by ELISA; and circulating endothelial cells (e.g., CD31, CD146, CD31, and CD133) by flow cytometry. Tumor biopsy samples are analyzed for microvessel density, VEGFR-2, VEGFR-3, HIF1-a, and PDGFR-b levels, and VEGF independent pathway by IHC.
After completion of study treatment, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed renal cell carcinoma
No known CNS disease
Previously treated brain metastases allowed provided there is no ongoing requirement for steroids AND no evidence of progression or hemorrhage for ≥ 3 months after treatment, as ascertained by clinical examination and brain MRI or CT scan
PATIENT CHARACTERISTICS:
None of the following conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Olivier Rixe, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000631737, NCI-09-C-0057, P08435 |
Study First Received: | January 9, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820209 |
Health Authority: | Unspecified |
stage IV renal cell cancer stage III renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer |
Epothilones Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Angiogenesis Modulating Agents Growth Inhibitors |